Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults (CAN-DO)

The goal of this clinical trial is to determine 1) feasibility of the MOMENT-V intervention for cannabis use disorder in young adults, 2) feasibility of conducting the trial remotely, and 3) whether the MOMENT-V intervention reduces cannabis use frequency and problems. Researchers will compare the MOMENT-V intervention to usual care enhanced by a counselor meeting.

Participants will either meet with a counselor two times and use an app on their phone for two weeks, or meet with a counselor briefly one time. All participants will be asked to complete electronic surveys, interviews with a research assistant, and saliva drug testing at home over three months.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cannabis Use Disorder
• Intervention / Treatment: Behavioral: Enhanced Usual Care; Behavioral: Motivational Enhancement Therapy plus Ecological Momentary Intervention

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

For the oral fluid testing pilot

Inclusion Criteria:

• Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice
• Participation in MOMENT-V open pilot
• Ownership of a smartphone
• Availability for the 2-week study duration

Exclusion Criteria:

• Inability/Unwillingness to provide contact information
• Current pregnancy or parenting

For the pilot RCT

Inclusion Criteria:

• Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice or Martha Eliot Health Center Adolescent Clinic
• 18 to 26 years old
• Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score of ≥12
• Recreational cannabis use on >3 days/week, on average, in the past 30 days
• Ownership of a smartphone that is PIN- or password-protected
• Ability to read and speak English
• Availability for the 6-month study duration

Exclusion Criteria:

• Inability/Unwillingness to provide contact information
• Written certification from a physician for marijuana for medical use
• Current participation in a substance use treatment program or research study
• Current pregnancy or parenting
• Participation in prior MOMENT or MOMENT-V research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Enhanced Usual Care arm; Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.	Behavioral: Enhanced Usual Care; Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.
Experimental: Intervention arm; Participants meet with a counselor 1-on-1 via videoconference and receive MOMENT-V (mHealth intervention involving 2 Motivational Enhancement Therapy [MET] sessions with a trained counselor and 2 weeks of smartphone-based Ecological Momentary Assessment [EMI]).	Behavioral: Motivational Enhancement Therapy plus Ecological Momentary Intervention; Two Motivational Enhancement Therapy (MET) sessions (1st, ~45 minutes; 2nd, ~30 minutes) between counselor and participant occur one week apart. MET sessions are personalized, interactive, face-to-face, and delivered according to a manual. MET session discussion topics include triggers for cannabis use, life goals/values, and development of a change plan. Participants then complete a 2-week Ecological Momentary Intervention (EMI) period. Survey prompts are sent 4x/day (3x/day at quasi-randomized times, 1x/day at fixed time; ~2 mins each) that ask about the participant's recent cannabis use. Depending on answers reported, the participant can receive tailored messages that support their self-efficacy and prompt use of coping strategies.; Other Names: MOMENT-V
No Intervention: Oral fluid test pilot; Prior to RCT, single-arm pilot to test feasibility and acceptability of remote oral fluid testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention completion	[Aim 1] Percent of participants assigned to the intervention arm completing the intervention (defined as both MET sessions and any EMI surveys). Benchmark: ≥80%	At week 3 (Upon completion of 2-week EMI period)
EMI engagement	[Aim 1] Percent of days on which participant responded to at least one survey during the 14 days of EMI. Benchmark: Median of ≥80% across intervention participants	In weeks 1-3 (during 2-week EMI period)
Acceptability: Overall satisfaction	[Aim 1] Satisfaction with intervention measured on the Client Satisfaction Questionnaire-8, an 8-item 4-point scale on which scores range from 8-32, with higher scores indicating greater satisfaction. Benchmark: ≥80% of participants with a scale score ≥24 (mean item score of ≥3 out 4)	At 6-month timepoint
Acceptability: Components	[Aim 1] Measure of acceptability (usability, likability, perceived effect, burden) for each intervention component (2 MET sessions and EMI). Components assessed with an 11- or 12-item 5-point Likert-type scales (1, Strongly Disagree to 5, Strongly Agree) developed for the study. Higher scores indicate greater acceptability. Benchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5	At week 0, week 1, and week 3
Screening	[Aim 2] Number of patients self-screening per month. Benchmark: ≥13 per month	During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
Eligibility	[Aim 2] Number of patients eligible per month. Benchmark: ≥6 per month	During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
Enrollment	[Aim 2] Number of patients enrolled per month. Benchmark: ≥3 per month	Upon enrollment
Retention in trial	[Aim 2] Percent of participants retained at each assessment time point (3 weeks, 3 months, 6 months, by assigned condition. Benchmark: ≥80% at each time point	At 3-week timepoint, 3-month timepoint, 6-month timepoint
Days of cannabis use	[Aim 3] Number of cannabis use days measured on Timeline Follow-Back (TLFB) calendar	At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
Times of cannabis use	[Aim 3] Number of cannabis use times measured on TLFB calendar	At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
Negative consequences of cannabis use	[Aim 3] Number of negative consequences (problems) measured on the 19-item Marijuana Problems Scale	At Baseline, 3-month timepoint, 6-month timepoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic alliance	[Aim 1] Working Alliance Inventory - Short Form, 12-items, 5-point Likert-type scale, total scale score and subscale scores (affective bond, perceived agreement on tasks, perceived agreement on goals; 4 items each), participant ("client") and observer versions reported separately and tested for agreement. Benchmark: ≥80% of participants with total score ≥48 (mean item score ≥4), participant version	At week 1
MET counselor adherence to MI principles	[Aim 1] Measure of counselor adherence to MI principles in each MET session, as reported by participant. Sessions assessed with 7- to 9-item 5-point Likert-type scales (Strongly Disagree to Strongly Agree) developed for the study. Benchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5	At week 0 and week 1
Duration of study activities	[Aim 2] Duration of each study activity (in minutes)	All timepoints, upon completion of each timepoint (Baseline, week 0, week 1, weeks 1-3 [two-week EMI period], 3-weeks, 3-months, 6-months)
Cannabis use disorder (CUD) symptoms	[Aim 3] Symptom count measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM)	At Baseline, 3-month timepoint, 6-month timepoint
Amount of THC used	[Aim 3] Number of standard THC units (1 unit = 5 mg THC) derived from number of familiar units (joints, vapes, gummies, etc.) x amount per unit (grams, milligrams, or milliliters) x estimated potency (% THC), measured on TLFB calendar. If unable to calculate standard THC units: Number of familiar units (joints, vapes, gummies, etc.)	At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
Motivation to change cannabis use	[Aim 3] One item each assessing readiness to, importance of, and confidence to change cannabis use, developed and used in our prior research, 11-point Likert-type scale for each. On follow-up, modified items about maintaining behavior if participant reports having started to change behavior but not having achieved change goals, or having changed behavior and achieved goals.	At Baseline, week 0, week 1, 3-months, 6-months
Psychological distress	[Aim 3] Kessler Psychological Scale-6 (K6), assessing frequency of experiencing 6 symptoms in the past month on a 5-point Likert-type scale, with coding such that high scores indicate greater psychological distress.	At Baseline, 3-month timepoint, 6-month timepoint
Cognitive function	[Aim 3] PROMIS Cognitive Function v.2.0 - Short Form 6a, 6 items, 5-point Likert-type response, measures participant-perceived cognitive deficits in the past 7 days. Age- and gender-weighted T scores, higher T-scores indicating better cognitive function.	At Baseline, 3-month timepoint, 6-month timepoint
Quality of life	[Aim 3] PROMIS Global Health v1.2, a 10-item, 5-point Likert-type response (except pain item 0-10), participant-reported measure of physical, mental, and social health, in general except for past 7 days for emotional problems, fatigue, and pain. Age- and gender-weighted T scores, higher T-scores indicating better quality of life.	At Baseline, 3-month timepoint, 6-month timepoint

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral fluid acceptability	[Exploratory Aim] Measure of acceptability (usability, likability, burden), 5 items, 5-point Likert-type scale (1, Strongly Disagree to 5, Strongly Agree), with higher scores indicating greater acceptability	At 2-week timepoint in oral fluid pilot phase; At 3-month timepoint and 6-month timepoint in pilot RCT phase
Oral fluid collection	[Exploratory Aim] Number and percent of videos of self-testing completed out of those expected, per participant Number and percent of observations of self-testing during study visit out of those expected, per participant	For 3 days before and on the day of 2-week timepoint in oral fluid pilot phase; For 3 days before and on the day of 3-month timepoint and at 6-month timepoint in pilot RCT phase
Oral fluid - self-reported cannabis use agreement	[Exploratory Aim] Agreement between oral fluid test results (positive/negative) and cannabis use reported on TLFB calendar for the day of testing or the day before testing (use/no use on either day)	For 3 days before and on the day of 2-week timepoint in oral fluid pilot phase; For 3 days before and on the day of 3-month timepoint and at 6-month timepoint in pilot RCT phase
Cannabis nonuse interval	[Exploratory Aim] Oral fluid test results for delta-9-tetrahydrocannabinol on 4 consecutive days (all negative = nonuse over 5 days/any positive = use within the 5 days)	For 4 days before and on the day of 2-week timepoint in oral fluid pilot phase; For 4 days before and on the day of 3-month timepoint and at 6-month timepoint in pilot RCT phase

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• Shrier LA, Burke PJ, Kells M, Scherer EA, Sarda V, Jonestrask C, Xuan Z, Harris SK. Pilot randomized trial of MOMENT, a motivational counseling-plus-ecological momentary intervention to reduce marijuana use in youth. Mhealth. 2018 Jul 30;4:29. doi: 10.21037/mhealth.2018.07.04. eCollection 2018.
• Shrier LA, Rhoads A, Burke P, Walls C, Blood EA. Real-time, contextual intervention using mobile technology to reduce marijuana use among youth: a pilot study. Addict Behav. 2014 Jan;39(1):173-80. doi: 10.1016/j.addbeh.2013.09.028. Epub 2013 Oct 4.
• Shrier LA, McCaskill NH, Smith MC, O'Connell MM, Gluskin BS, Parker S, Everett V, Burke PJ, Harris SK. Telehealth counseling plus mHealth intervention for cannabis use in emerging adults: Development and a remote open pilot trial. J Subst Use Addict Treat. 2024 Nov;166:209472. doi: 10.1016/j.josat.2024.209472. Epub 2024 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: behavioral intervention; young adult; cannabis use
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Abuse; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: IRB-P00049240; 1R34DA060500-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified survey and oral fluid testing data
• IPD Sharing Time Frame: De-identified scientific data will be shared as soon as possible. De-identified scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years.
• IPD Sharing Access Criteria: De-identified scientific data and metadata arising from the project will be archived in the openICPSR repository. De-identified scientific data from this project will be findable through summary information (metadata) that will be readily available on the Center for Adolescent Behavioral Health Research website, the repository website, and clinicaltrials.gov.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No